Formulation And Process Development Strategies For Manufacturing Biopharmaceuticals

Publisher: Wiley
ISBN: 0470118121
Size: 29.77 MB
Format: PDF, ePub, Docs
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A real-world guide to the production and manufacturing of biopharmaceuticals

While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging.

Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes:

  • Research and early development phase–appropriate approaches for ensuring product stability

  • Development of commercially viable formulations for liquid and lyophilized dosage forms

  • Optimal storage, packaging, and shipping methods

  • Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions

  • Useful analysis of successful and failed products

Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.

Pharmaceutical Preformulation And Formulation

Author: Mark Gibson
Publisher: CRC Press
ISBN: 1420073184
Size: 63.91 MB
Format: PDF, Mobi
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The book meets the need for advanced information for drug preformulation and formulation and addresses the current trends in the continually evolving pharmaceutical industry.

Process Scale Purification Of Antibodies

Author: Uwe Gottschalk
Publisher: John Wiley & Sons
ISBN: 1119126932
Size: 18.91 MB
Format: PDF, Docs
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Promoting a continued and much-needed renaissance in biopharmaceutical manufacturing, this book covers the different strategies and assembles top-tier technology experts to address the challenges of antibody purification. • Updates ...

Quality By Design For Biopharmaceuticals

Author: Anurag S. Rathore
Publisher: John Wiley & Sons
ISBN: 1118210913
Size: 28.62 MB
Format: PDF, ePub, Mobi
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The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the ...

Monoclonal Antibodies

Author: Steven Shire
Publisher: Woodhead Publishing
ISBN: 0081002971
Size: 24.59 MB
Format: PDF, ePub
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Monoclonal Antibodies discusses the challenges and issues revolving around development of a monoclonal antibody produced by recombinant DNA technology into a therapeutic agent.This book covers downstream processing which includes design of ...

Sterile Product Development

Author: Parag Kolhe
Publisher: Springer Science & Business Media
ISBN: 1461479789
Size: 17.73 MB
Format: PDF, ePub, Docs
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This comprehensive book encompasses various facets of sterile product development.